algorithm using linq sensors for evaluation and treatment of heart failure

Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class III

Summary: the alleviate-hf study is a prospective, randomized, controlled, blinded, multi-site, interventional, investigational device exemption (ide) pivotal study. the purpose of the study is to demonstrate the safety and efficacy of a patient management pathway that utilizes an integrated device diagnostic-based risk stratification algorithm to guide patient care in subjects with nyha class ii and iii heart failure, and to demonstrate the safety of the reveal linq™ system and procedure in the study population.

the study will utilize the market released reveal linq™ insertable cardiac monitor with an investigational alleviate-hf ramware download. the study will enroll up to 900 subjects at up to 75 sites in the us. subjects will be followed until the last enrolled subject is followed for 7 months or until the end of the study, whichever occurs first, or until time of study exit or death as applicable, but no longer than 36 months.

Eligibility criteria:
inclusion criteria: * patient has nyha class ii or iii heart failure per most recent assessment, irrespective of left ventricular ejection fraction (lvef) * patient has documented recent history of symptomatic heart failure, defined as meeting any one of the following three criteria: 1. hospital admission with primary diagnosis of hf within the last 12 months, or 2. intravenous hf therapy (e.g. iv diuretics/vasodilators) or ultrafiltration within the last 6 months, or 3. patient had the following bnp/nt-probnp within the last 3 months: if lvef ≥ 50%, then bnp\> 150 pg/ml or nt-probnp \> 450 pg/ml or if lvef is \ 300 pg/ml or nt-probnp \> 900 pg/ml * patient is willing and able to comply with the protocol, including linq icm insertion, carelink transmissions (including adequate connectivity), study visits and remote care directions. * patient is 18 years of age or older. * patient has a life expectancy of 12 months or more. exclusion criteria: * patient is currently implanted with a cardiovascular implantable electronic device (cied) (e.g. icm, pacemaker, icd, crt-d or crt-p device) or hemodynamic monitor. * patient is receiving temporary or permanent mechanical circulatory support. * patient had mi or pci/cabg within past 90 days. * patient has had a heart transplant, or is currently on heart transplant list. * patient has severe valve stenosis on echocardiogram. * patient has primary pulmonary hypertension (pre-capillary, who group 1,3,4,5). * patient is on chronic intravenous inotropic drug therapy (e.g. dobutamine, milrinone). * patient has severe renal impairment (egfr \<30 ml/min). * patient has systolic blood pressure of \< 90 mmhg at the time of enrollment. * patient is on chronic renal dialysis. * patient is unable to undergo one round of prn medication intervention (i.e. 4 days of increased diuretics dose). * patient has liver disease, defined as ast/alt \>5x normal, or bilirubin \>2x normal. * patient has serum albumin \< 3 g/dl. * patient has hypertrophic obstructive cardiomyopathy, constrictive pericarditis or amyloidosis. * patient has complex adult congenital heart disease. * patient has active cancer involving chemotherapy and/or radiation therapy. * patient weighs more than 500 pounds. * patient is pregnant or breastfeeding (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment). * patient is enrolled in another interventional study.

Keywords: heart failure insertable cardiac monitor